Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.).
- Create or review and approve CDISC-compliant datasets and corresponding. documentation for electronic submission to regulatory agencies.
- Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
- Assist statisticians by suggesting algorithms to address Client analysis requests.
- Develop software validation procedures and test plans, as necessary.
- Create and document archives of software, outputs, and analysis files.
- Create and maintain department SOPs related to clinical programming.
- Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
- Oversee work of internal contract programmers and external vendors.
- Provide time and resource estimates for project planning.
Requirements:
- Minimum of 6 years of experience in developing software for clinical trials using the SAS system.
- Skilled in programming with SAS. Knowledge of additional programming languages a plus.
- Good knowledge of statistics and Oncology drug development process.
- Experience as a lead programmer for NDAs/BLAs.
- Experience overseeing the work of internal contractors and external vendors (CROs).
- Experience in pharmacokinetics/pharmacodynamics modelling a plus.
- Familiarity with CDISC standards, including SDTM and Adam models. Solid verbal and written communication skills.